Comparative Study of Three Collagen Membranes: 1 Non-cross-linked and 2 Cross-linked

Conditions

• Bone Regeneration

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Membrane Jason MB GmbH Non-cross-linked (NCL) — DEVICE
  The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
• Membrane BioMend Extend Glutaraldehyde cross-linked — DEVICE
  The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
• Membrane OSSIX Agile Ribose cross-linked (RCL) — DEVICE
  The membrane will be stabilized in the oral mucosa using sutures and flowable composite.

Study Details

This study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth. These membranes are often used in dental and oral surgery to help with healing and tissue growth. The goal is to find out if one membrane lasts longer than the others, which may help doctors choose the best option for different procedures. In this study, the membranes will be placed in the mouth in a specific area near the gums of the upper back teeth. The study is designed so that neither the patients nor the researchers evaluating the results will know which membrane is which (this is called a double-blind study). Over time, researchers will measure how much each membrane has broken down. This information may help improve treatment planning and patient outcomes in dental care.

Key Dates

Start date

Apr 28, 2025

Status verified

Feb 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: OSSIX - BioMend - Jason
  Possible unique ordering of the 3 different membranes to which participants may be randomized
• Active Comparator: BioMend - OSSIX - Jason
  Possible unique ordering of the 3 different membranes to which participants may be randomized
• Active Comparator: BioMend - Jason - OSSIX
  Possible unique ordering of the 3 different membranes to which participants may be randomized
• Active Comparator: Jason - OSSIX - BioMend
  Possible unique ordering of the 3 different membranes to which participants may be randomized
• Active Comparator: Jason - BioMend - OSSIX
  Possible unique ordering of the 3 different membranes to which participants may be randomized
• Active Comparator: OSSIX - Jason - BioMend
  Possible unique ordering of the 3 different membranes to which participants may be randomized

Primary Outcome Measure

Degradation rates of three different collagen membranes simulating exposure to the oral environment. [ Time Frame: 10 days ]

Locations (1)

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